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Observational Study of the Durability of Seroconversion Chronic HBV Patients Who Seroconverted in a Previous Gilead-Sponsored Study of ADV.

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ClinicalTrials.gov Identifier: NCT00158717
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 7, 2014
Sponsor:
Information provided by:
Gilead Sciences

Study Description
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Brief Summary:
To investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B virus infection (HBV) who have seroconverted while participating in a previous Gilead-sponsored study of adefovir dipivoxil.

Condition or disease Intervention/treatment
Hepatitis B Drug: Hepsera

Detailed Description:

The primary objective of this study is to investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B virus infection (HBV) who have seroconverted while participating in a previous Gilead-sponsored study of adefovir dipivoxil.

The secondary objective of this study is to investigate the durability of HBeAg loss in patients with chronic hepatitis B virus infection (HBV) who have experienced durable HBeAg loss while participating in a previous Gilead-sponsored study of adefovir dipivoxil.

Study Design
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Study Type : Observational
Actual Enrollment : 107 participants
Official Title: A Phase 3b, Long-Term, Observational Study of the Durability of Seroconversion in Patients With Chronic Hepatitis B Virus Infection Who Have Seroconverted While Participating in a Previous Gilead-Sponsored Study of Adefovir Dipivoxil.
Study Start Date : April 2003
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Durability of HBeAg seroconversion in patients with chronic hepatitis B virus infection (HBV) who have seroconverted while participating in a previous Gilead-sponsored study of adefovir dipivoxil. [ Time Frame: Baseline to Week 144 ]

Secondary Outcome Measures :
  1. Durability of HBeAg loss in patients with chronic hepatitis B virus infection (HBV) who have experienced durable HBeAg loss while participating in a previous Gilead-sponsored study of adefovir dipivoxil. [ Time Frame: Baseline to Week 144 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who demonstrate HBeAg seroconversion or durable HBeAg loss in one of the previous Gilead-sponsored studies listed in Section 4.2 of this protocol and meet all inclusion and none of the exclusion criteria for this study will be eligible for enrollment.
Criteria

Inclusion Criteria:

  • Must have met all inclusion criteria and none of the exclusion criteria and must have demonstrated HBeAg seroconversion or durable HBeAg loss as defined by the protocol in one of the following Gilead-sponsored studies: GS-96-412, GS-98-437, GS-00-461 or ongoing or future Gilead-sponsored studies identified by the Sponsor to be eligible for this study. Other patients who were enrolled in a now closed Gilead-sponsored study of ADV (GS-94-404, GS-96-412 Initial Phase or GS-96-413) and had previously demonstrated seroconversion or durable HBeAg loss during their participation will be evaluated by the clinical research organization (CRO) medical monitor for participation in this study on a case by case basis.
  • Have documented negative serum HBeAg with or without positive anti-HBe present at the two study visits prior to the final visit of the previous study.
  • A patient who has documented negative serum HBeAg without positive anti-HBe must also have undetectable serum HBV DNA (less than 1000 copies/mL using Roche Amplicor PCR Assay) and normalized ALT (less than ULN) confirmed during these two studies.
  • All patients must be able to give written informed consent and comply with requirements of this study.

Exclusion Criteria:

  • Patients who seroconvert or experience durable HBeAg loss during their participation in study GS-00-480 will not be eligible.
  • Any serious or active medical or psychiatric illness that, in the opinion of the investigator would interfere with patient treatment, assessment or compliance with the protocol.
  • Receiving any of the excluded medications listed in the protocol.
  • Inability to comply with study requirements.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00158717    
Other Study ID Numbers: GS-00-481
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014
Keywords provided by Gilead Sciences:
Chronic Hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action